普卢利沙星胶囊处方的优选

目的：筛选普卢利沙星胶囊的最佳处方组成。方法：以辅料中的丙二醇、低取代羟丙基纤维素（L-HPC）、粘合剂（2％K-30稀乙醇溶液和8％淀粉浆）作为考察因素，每个因素取2个水平，用L4（2^3）正交表安排试验，以普卢利沙星胶囊的溶出度为主要考察指标，以颗粒流动性和外观为参照指标，进行正交试验。结果：辅料中影响胶囊溶出度的主要因素是丙二醇（P〉0．05），最佳处方组成为丙二醇8g、低取代羟丙基纤维素（L-HPC）5g、滑石粉1g、乳糖20g、2％K-30稀乙醇溶液适量。结论：采用该处方及工艺制得的普卢利沙星胶囊溶出度较高，而且产品质量稳定，制备工艺简单可行，适合工业化生产。

Study on Formulation and Preparation of Prulifloxacin Capsule

Objective:To optimize the best formulation technique of Prulifloxacin capsule.Methods:The L4 (23) orthogonal table and three factors (dissolution,the grain liquidity and appearance as reference factors)were used to select the best formulation by taking propanediol,with low substituted hydroxypropyl cellulose(L-HPC) and binder (2% K-30 dilute ethanol solution and 8% starch plasm) as the three main factors,and two levels were adopted for each factor.Results:The experimental results indicated that propanediol was the chief factor of influencing dissolution of Prulifloxacin capsule (P>0.05),low substituted hydroxypropyl cellulose (L-HPC) and binder had no statistic significance.The best formulation was composed of the following,propanediol 8 g,L-HPC 5 g,talc powder 1 g,lactose 20 g,appropriate amount of 2% K-30 dilute ethanol solution.Conclusion:The optimum formulation and preparing technique are reliable.The quality of Prulifloxacin capsule accord with China pharmacopoeia standard.Because the preparing technique is simple and feasible,it is suitable for industrialized production.